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USFDA EIR obtained by Lupin for unit 3 of the Pithampur facility

Updated: Dec 18, 2018

An EIR (Establishment Inspection Report) form the U.S regulator has been received for unit 3 facility in Madhya Pradesh of Lupin limited, which is a multinational pharmaceutical company based in Mumbai.

According to the accustomed sources, an inspection was carried out from June 12th till June 16th in the year 2017 for the unit 3 of Pithampur facility. It was stated by Lupin in a BSE filing that this was a preapproval inspection of a product called as Albuterol Sulfate Inhalation. "Receiving the Establishment Inspection Report (EIR) for Unit 3 facility of Pithampur is quite an inspirational development," said Nilesh Gupta, Managing director of Lupin limited. He also added that this is actually a confirmation that the company is devoted to maintaining the elevated standard in compliance and maintaining quality.

An establishment Inspection Report (EIR) is issued by U.S Food and Drug Administration (USFDA) to a facility that comes under the USFDA or during scrutiny by the contracted agency of FDA when it decides that the inspection will be closed. USDFA has given the term Establishment Inspection report (EIR) for the whole account of what has been done by the investigator of FDA in all the time spent in the organization, form the introduction period to the inspectional surveillance delivery.

By chance this happened a week before the completion of the inspection by USFDA at Mandideep location that serves as an organizer to the company’s solid oral dosage form facility and pril API facilities of Cardiovascular and Cephalosporin. The inspection has taken place from 26th of November till 4th December, 2018.

Lupin's stock was trading at 824.15 on BSE which was 1.88 % less from its previous close, despite receiving an EIR from FDA. The company is a manufacturer of dermatological products, metered dose inhalers, dry powder inhalers.